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Clinical Study on the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies

Primary Purpose

Hematological Malignancies

Status

Not yet recruiting

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

NK cells/Combined Monoclonal Antibodies

About this trial

This is an interventional treatment trial for Hematological Malignancies

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed diagnosis of AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
Relapsed or refractory AML (meeting one of the following conditions):
1. CR not achieved after standardized chemotherapy;
2. CR achieved following the first induction, but CR duration is less than 12 months;
3. Ineffectively after first or multiple remedial treatments;
4. 2 or more relapses;
The number of primordial cells in bone marrow is > 5% (by morphology), and/or > 0.01% (by flowcytometry);
Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
Estimated survival time ≥ 3 months;
ECOG performance status 0 to 2;
Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.

Exclusion Criteria:

History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases;
Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past;
Pregnant (or lactating) women;
Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis);
Active infection of hepatitis B virus or hepatitis C virus;
Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids;
Previously treated with any CAR-T cell product or other genetically- modified T cell therapies;
Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
Other uncontrolled diseases that were not suitable for this trial;
Patients with HIV infection;
Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study.

Sites / Locations

The First Affiliated Hospital, College of Medicine, Zhejiang University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Administration of NK cells/Combined Monoclonal Antibodies

Arm Description

Outcomes

Primary Outcome Measures

Dose-limiting toxicity (DLT)

Adverse events assessed according to NCI-CTCAE v5.0 criteria

Incidence of treatment-emergent adverse events (TEAEs)

Incidence of treatment-emergent adverse events [Safety and Tolerability]

Secondary Outcome Measures

Acute Myeloid Leukemia (AML), Overall response rate (ORR)

Assessment of ORR (ORR = CR + CRi) at Month 6, 12, 18 and 24

AML, Overall survival (OS)

From the first infusion of NK cells/Combined Monoclonal Antibodies to death or the last visit

AML, Event-free survival (EFS)

From the first infusion of NK cells/Combined Monoclonal Antibodies to the occurrence of any event, including death, relapse or generelapse, disease progression (any one occurs first), and the last visit

Quality of life

Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale [For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12

Activities of Daily Living (ADL) score

Assessment using Activities of Daily Living (ADL) scale (Barthel Index) [max score: 100, min score: 0, higher scores mean a better outcome] at Baseline, Month 1, 3, 6, 9 and 12

Instrumental Activities of Daily Living (IADL) score

Assessment of Instrumental Activities of Daily Living (IADL) scale [max score: 56, min score: 14, higher scores mean a worse outcome] at Baseline, Month 1, 3, 6, 9 and 12

Hospital Anxiety and Depression Scale (HADS) score

Assessment using Hospital Anxiety and Depression Scale (HADS) [max score: 42, min score: 0, higher scores mean a worse outcome] at Baseline, Month 1, 3, 6, 9 and 12

Full Information

NCT ID

NCT04662788

First Posted

December 8, 2020

Last Updated

December 8, 2020

Sponsor

Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04662788

Brief Title

Clinical Study on the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies

Official Title

Clinical Trial for the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 1, 2021 (Anticipated)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Clinical study on the safety and effectiveness of NK cells/combined monoclonal antibodies in the treatment of hematological malignancies

Detailed Description

This is a single arm, open-label, single-center study. This study is indicated for hematological malignancies. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematological Malignancies

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Administration of NK cells/Combined Monoclonal Antibodies

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

NK cells/Combined Monoclonal Antibodies

Intervention Description

Each subject receive NK cells/Combined Monoclonal Antibodies

Primary Outcome Measure Information:

Title

Dose-limiting toxicity (DLT)

Description

Adverse events assessed according to NCI-CTCAE v5.0 criteria

Time Frame

Baseline up to 28 days after NK cells/Combined Monoclonal Antibodies infusion

Title

Incidence of treatment-emergent adverse events (TEAEs)

Description

Incidence of treatment-emergent adverse events [Safety and Tolerability]

Time Frame

Up to 2 years after NK cells/Combined Monoclonal Antibodies infusion

Secondary Outcome Measure Information:

Title

Acute Myeloid Leukemia (AML), Overall response rate (ORR)

Description

Assessment of ORR (ORR = CR + CRi) at Month 6, 12, 18 and 24

Time Frame

At Month 1, 3, 6, 12, 18 and 24

Title

AML, Overall survival (OS)

Description

From the first infusion of NK cells/Combined Monoclonal Antibodies to death or the last visit

Time Frame

Up to 2 years after NK cells infusion

Title

AML, Event-free survival (EFS)

Description

Time Frame

Up to 2 years after NK cell/ Combined Monoclonal Antibodies infusion

Title

Quality of life

Description

Time Frame

At Baseline, Month 1, 3, 6, 9 and 12

Title

Activities of Daily Living (ADL) score

Description

Assessment using Activities of Daily Living (ADL) scale (Barthel Index) [max score: 100, min score: 0, higher scores mean a better outcome] at Baseline, Month 1, 3, 6, 9 and 12

Time Frame

At Baseline, Month 1, 3, 6, 9 and 12

Title

Instrumental Activities of Daily Living (IADL) score

Description

Assessment of Instrumental Activities of Daily Living (IADL) scale [max score: 56, min score: 14, higher scores mean a worse outcome] at Baseline, Month 1, 3, 6, 9 and 12

Time Frame

At Baseline, Month 1, 3, 6, 9 and 12

Title

Hospital Anxiety and Depression Scale (HADS) score

Description

Assessment using Hospital Anxiety and Depression Scale (HADS) [max score: 42, min score: 0, higher scores mean a worse outcome] at Baseline, Month 1, 3, 6, 9 and 12

Time Frame

At Baseline, Month 1, 3, 6, 9 and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed diagnosis of AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1); Relapsed or refractory AML (meeting one of the following conditions): CR not achieved after standardized chemotherapy; CR achieved following the first induction, but CR duration is less than 12 months; Ineffectively after first or multiple remedial treatments; 2 or more relapses; The number of primordial cells in bone marrow is > 5% (by morphology), and/or > 0.01% (by flowcytometry); Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L; Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%; Estimated survival time ≥ 3 months; ECOG performance status 0 to 2; Patients or their legal guardians volunteer to participate in the studyand sign the informed consent. Exclusion Criteria: History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases; Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past; Pregnant (or lactating) women; Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis); Active infection of hepatitis B virus or hepatitis C virus; Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids; Previously treated with any CAR-T cell product or other genetically- modified T cell therapies; Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl; Other uncontrolled diseases that were not suitable for this trial; Patients with HIV infection; Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

He Huang, PhD

Phone

86-13605714822

hehuangyu@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yongxian Hu, PhD

Phone

86-15957162012

huyongxian2000@aliyun.com

Facility Information:

Facility Name

The First Affiliated Hospital, College of Medicine, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

Country

China

12. IPD Sharing Statement

Learn more about this trial

Clinical Study on the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies

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